TL;DR
The GLP-1 that proved cardiovascular benefit even in patients without a prior heart attack.
What is it? Eli Lilly's once-weekly GLP-1, fused to an IgG4 antibody fragment so it gets recycled by the immune system instead of cleared. Half-life about 5 days. FDA-approved as Trulicity in 2014.
What does it do? Standard GLP-1 receptor agonist play: glucose-dependent insulin secretion, glucagon suppression, slower gastric emptying, less appetite. HbA1c drops 0.7–1.6%. Weight loss is modest at 2–5 kg.
Does the evidence hold up? Yes. The AWARD program (AWARD 1 through AWARD 11) covered the diabetes label. REWIND in 2019 cut MACE 12% in T2D adults including those without prior cardiovascular events.
Who uses it? T2D patients on a once-weekly pen. Now also for cardiovascular risk reduction since 2020. Mostly stayed in the diabetes lane while semaglutide and tirzepatide moved into obesity.
Bottom line? Reliable diabetes drug. Real cardiovascular outcomes. Modest weight loss compared to its newer cousins.
What It Is
Dulaglutide (brand name Trulicity; development code LY2189265) is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist biologic developed by Eli Lilly and Company. Chemically, it is a homodimer of two identical chains, each consisting of a modified human GLP-1(7-37) analog linked via a small peptide spacer to a modified human IgG4 Fc heavy-chain fragment. The GLP-1 portion carries substitutions (Gly8, Glu22, Gly36) that confer resistance to DPP-4 cleavage, while the IgG4 Fc is engineered to minimize Fcγ-receptor binding and immune effector function. The total molecular weight is approximately 63 kilodaltons — very large relative to native GLP-1 (about 3.3 kDa) and about 10× larger than semaglutide.
The molecule is produced in Chinese hamster ovary (CHO) cells via recombinant DNA technology and purified as a sterile solution for subcutaneous injection. It is supplied in a pre-filled single-dose pen (Trulicity pen) at strengths of 0.75 mg, 1.5 mg, 3.0 mg, and 4.5 mg per 0.5 mL. Once-weekly dosing is enabled by the roughly 5-day elimination half-life, which results from a combination of the Fc-mediated FcRn recycling (extending plasma residence) and the large molecular size (slowing renal clearance).
Dulaglutide was first approved by the U.S. FDA in September 2014 for the treatment of type 2 diabetes mellitus in adults, based on the AWARD Phase 3 program. In February 2020, the label was expanded to include cardiovascular risk reduction in adults with T2D who have established cardiovascular disease or multiple cardiovascular risk factors, based on the REWIND trial — notably, the first GLP-1 CV outcomes trial to include a majority (68%) of participants without established CVD at baseline. In June 2020, the FDA approved two higher doses (3.0 mg and 4.5 mg weekly) under the AWARD-11 trial program for enhanced glycemic control.
In the broader GLP-1 landscape of 2026, dulaglutide sits at a specific point in the efficacy/tolerability/convenience trade-off: slightly less potent than semaglutide for HbA1c lowering and weight loss, meaningfully less potent than tirzepatide (the GIP/GLP-1 co-agonist), but delivered via an arguably more user-friendly single-dose pen and with cardiovascular benefit established in a primary-prevention-enriched population (REWIND). It is not FDA-approved for obesity as a standalone indication; Eli Lilly advanced tirzepatide (Zepbound) as its obesity product rather than pursuing a Trulicity obesity label.
Mechanism of Action
Dulaglutide activates the GLP-1 receptor (a class-B G protein-coupled receptor, Gαs-coupled) on multiple tissues — pancreatic beta cells, alpha cells, hypothalamic neurons, gastric smooth muscle, and cardiovascular tissues. The downstream effects reproduce those of endogenous GLP-1 but sustain them at pharmacologic concentrations for approximately a week per injection.
- Glucose-dependent insulin secretion — Binding to beta-cell GLP-1 receptors activates adenylate cyclase, raising intracellular cAMP. cAMP amplifies glucose-stimulated insulin secretion only when blood glucose is elevated — insulin release returns to baseline when glucose normalizes. This glucose-dependence is the principal reason GLP-1 agonists rarely cause hypoglycemia as monotherapy (hypoglycemia risk rises when combined with insulin or sulfonylureas).
- Glucagon suppression — Reduces alpha-cell glucagon secretion in the postprandial state, diminishing hepatic glucose output. Combined with insulin augmentation, this narrows the glucose-excursion curve after meals.
- Delayed gastric emptying — Slows gastric motility via vagal pathways and local smooth-muscle relaxation. Reduces the rate at which glucose and nutrients reach the small intestine, flattening the postprandial glucose spike and prolonging satiety. Gastric-emptying delay is the principal mechanism behind the nausea that many patients experience in the initial weeks of therapy.
- Central appetite reduction — GLP-1 receptors in the arcuate and paraventricular nuclei of the hypothalamus, the area postrema, and the nucleus tractus solitarius mediate satiety signaling. Chronic GLP-1R activation produces sustained appetite reduction and meal-size decrease — the dominant mechanism behind weight loss in this drug class.
- Beta-cell effects (mechanism, not label) — In preclinical models, GLP-1 agonists preserve beta-cell mass and improve glucose-stimulated insulin secretion capacity. Translation to clinical beta-cell preservation in humans is suggestive but not a labeled claim.
- Cardiovascular effects — Direct vascular GLP-1R activation contributes to modest blood-pressure reduction, endothelial function improvement, and a favorable shift in lipid parameters. The REWIND trial demonstrated a 12% MACE reduction with dulaglutide vs placebo over 5.4 years median follow-up, independent of baseline HbA1c or CV risk status.
- Renal effects — Meta-analyses of GLP-1 agonist CV outcomes trials suggest reduced composite renal outcomes (new-onset macroalbuminuria, eGFR decline, renal replacement therapy). REWIND's prespecified renal secondary endpoints favored dulaglutide.
- IgG4 Fc fusion pharmacology — The IgG4 Fc fragment is engineered to minimize Fcγ-receptor binding and complement activation while retaining FcRn-mediated pinocytic recycling. The FcRn recycling extends half-life by salvaging the molecule from lysosomal degradation after endocytosis — the same mechanism that gives therapeutic IgG antibodies their multi-week half-lives.
- What it does not do — Dulaglutide does not activate the GIP receptor (the basis of tirzepatide's additional metabolic effects), does not engage amylin receptors, and does not act directly on the melanocortin system. It is a single-target GLP-1 agonist with the class-characteristic profile.
What the Research Shows
Dulaglutide's evidence base is built on the AWARD Phase 3 program (eleven numbered trials), the REWIND cardiovascular outcomes trial, and an expanding set of real-world and head-to-head studies.
- AWARD-1 (Wysham 2014, Diabetes Care; PMID 24898306) — Dulaglutide 1.5 mg or 0.75 mg weekly vs exenatide twice-daily vs placebo, with metformin and pioglitazone background. Dulaglutide 1.5 mg superior to exenatide for HbA1c reduction at 26 weeks.
- AWARD-2 (Giorgino 2015, Diabetes Care; PMID 26246459) — Dulaglutide vs insulin glargine, both added to metformin + glimepiride. Dulaglutide 1.5 mg non-inferior and then superior to glargine for HbA1c reduction at 52 weeks with lower hypoglycemia and weight loss vs weight gain.
- AWARD-3 (Umpierrez 2014, Diabetes Care; PMID 25114296) — Dulaglutide monotherapy vs metformin. Dulaglutide 1.5 mg superior to metformin for HbA1c reduction at 26 weeks.
- AWARD-5 (Nauck 2014, Diabetes Care; PMID 24842984) — Dulaglutide vs sitagliptin, both added to metformin. Dulaglutide superior at 52 weeks.
- AWARD-6 (Dungan 2014, Lancet; PMID 25220191) — Dulaglutide 1.5 mg vs liraglutide 1.8 mg daily, both added to metformin. Dulaglutide non-inferior on HbA1c reduction at 26 weeks. Established head-to-head parity with liraglutide.
- AWARD-7 (Tuttle 2018, Lancet Diabetes Endocrinol; PMID 29937267) — Dulaglutide vs insulin glargine in patients with moderate-to-severe CKD. Dulaglutide non-inferior for HbA1c; beneficial renal profile. Informed dosing in CKD populations.
- AWARD-11 (Frias 2021, Diabetes Care; PMID 33334807) — Dose-response trial: dulaglutide 1.5, 3.0, and 4.5 mg weekly, with metformin background. Dose-dependent additional HbA1c reduction and weight loss at 3.0 and 4.5 mg; tolerability similar across doses. Basis for the 2020 FDA approval of 3.0 and 4.5 mg doses.
- REWIND (Gerstein 2019, Lancet; PMID 31189511) — Double-blind, randomized, placebo-controlled CV outcomes trial. 9,901 adults with T2D plus either established CVD or CV risk factors. Median follow-up 5.4 years. Primary endpoint (first occurrence of MACE — CV death, nonfatal MI, nonfatal stroke): HR 0.88 (95% CI 0.79–0.99, P=0.026). 68% of participants had no established CVD at baseline — notable because most prior GLP-1 CV outcome trials enrolled almost exclusively secondary-prevention populations.
- REWIND renal outcomes (Gerstein 2019, Lancet; PMID 31189512) — Prespecified secondary analysis. Composite renal outcome (new macroalbuminuria, sustained eGFR decline ≥30%, renal replacement): HR 0.85 (95% CI 0.77–0.93, P=0.0004). Favors dulaglutide.
- REWIND cognitive outcomes (Cukierman-Yaffe 2020, Lancet Neurol; PMID 32534650) — Prespecified exploratory analysis. Substantive cognitive impairment outcome HR 0.86 (95% CI 0.79–0.95, P=0.0018) after adjustment for baseline cognition. The first GLP-1 CV trial to report a cognitive benefit signal.
- SUSTAIN-7 (not dulaglutide, but relevant) — Head-to-head semaglutide vs dulaglutide. Semaglutide 1.0 mg weekly superior to dulaglutide 1.5 mg for both HbA1c reduction and weight loss. This result, combined with tirzepatide's superior efficacy, has gradually shifted market share.
- Limitations — Dulaglutide has not been tested as an obesity monotherapy; it is not FDA-approved for that indication. Weight loss in the AWARD trials averaged 2–5 kg — clinically meaningful for T2D but modest vs semaglutide 2.4 mg (approximately 15%) or tirzepatide (approximately 20%).
Research Context
Dulaglutide is a well-validated FDA-approved GLP-1 agonist with a broader cardiovascular outcomes footprint (REWIND) than most of its peers because of the primary-prevention enrichment of the trial. For pure HbA1c lowering and weight loss, semaglutide and tirzepatide have superior efficacy. For simplicity of administration (pre-filled single-dose pen, no titration needles), dulaglutide retains a usability advantage. For obesity as a standalone indication, other compounds are the right choice — dulaglutide is not obesity-labeled.
Human Data
The human evidence base is exceptionally large by any standard, and particularly so compared to most compounds on this database.
- AWARD Phase 3 program (AWARD 1 through AWARD 11) — Eleven randomized controlled trials covering dulaglutide monotherapy, combinations with metformin/sulfonylurea/insulin/SGLT2 inhibitor background, head-to-head vs exenatide, glargine, sitagliptin, liraglutide, and sitagliptin, plus dose-finding at 3.0 and 4.5 mg. The program collectively enrolled more than 10,000 patients.
- REWIND (9,901 patients, 5.4-year median follow-up) — The pivotal CV outcomes trial. Primary MACE reduction, plus prespecified renal and cognitive-outcome benefits.
- AWARD-CHF (Ferreira 2021) — Patients with T2D and heart failure with preserved ejection fraction (HFpEF). Additional supportive data in HF-preserved populations.
- Post-marketing pharmacovigilance — More than 10 years of post-marketing safety data since 2014 FDA approval. Thyroid C-cell tumor signal remains rodent-only; human thyroid cancer surveillance has not surfaced a clinical signal of concern.
- Real-world evidence — Large-scale retrospective cohort analyses in Medicare and commercial-payer populations confirming the HbA1c and weight-loss profile seen in trials, with the expected attrition and adherence pattern of chronic injectable therapy.
- Pediatric trial (AWARD-PEDS) — A Phase 3 trial in pediatric T2D led to expanded FDA approval for pediatric patients aged 10 years and older in 2022.
- No obesity-indication trial — Eli Lilly did not pursue a dedicated obesity Phase 3 for dulaglutide; the obesity pipeline at Lilly became tirzepatide (Zepbound) and retatrutide (Phase 3, GLP-1 / GIP / glucagon triagonist).
Dosing from the Literature
FDA-approved labeling. All doses delivered subcutaneously once weekly via the Trulicity pre-filled single-dose pen; no self-reconstitution required.
| Indication | Starting Dose | Maintenance Dose | Notes |
|---|
| Type 2 diabetes — glycemic control | 0.75 mg SubQ weekly | Titrate to 1.5 mg weekly after ≥4 weeks if additional glycemic control is needed | Some patients remain on 0.75 mg long-term if tolerability is limiting. |
| Type 2 diabetes — additional glycemic control | Increase to 3.0 mg weekly from 1.5 mg after ≥4 weeks | Increase to 4.5 mg weekly from 3.0 mg after ≥4 weeks if needed | AWARD-11 basis. Titrate slowly to manage GI tolerability. |
| T2D with established CVD or CV risk factors | 0.75 mg weekly starting dose | 1.5 mg weekly (REWIND dose) | CV risk-reduction indication uses the 1.5 mg dose, the dose tested in REWIND. |
| Pediatric T2D (age ≥10) | 0.75 mg weekly | Titrate to 1.5 mg weekly as needed | 2022 pediatric approval. |
| Renal impairment | No dose adjustment | Same as above | Can be used across eGFR ranges; AWARD-7 supported CKD dosing. |
| Hepatic impairment | No specific adjustment | Same as above | Use with caution in severe impairment — limited data. |
Dosing Disclaimer
Dulaglutide is a prescription pharmaceutical. All dosing decisions should be made by a licensed prescribing clinician. The single-dose pen is designed to deliver a fixed dose; cutting or modifying the device is not supported by the manufacturer. Injection sites should be rotated (abdomen, thigh, or upper arm); SubQ only — do not administer intramuscularly or intravenously. The pen should be brought to room temperature before injection for patient comfort.
Reconstitution & Storage
Dulaglutide is supplied as a pre-filled single-dose pen in a sterile solution ready for injection. No reconstitution is required or supported.
| Form | Dose Strength | Storage (Unopened) | Storage (In Use) |
|---|
| Trulicity single-dose pen | 0.75 mg / 0.5 mL | 2–8°C refrigerated, protected from light | Up to 14 days at room temp (<30°C) if needed |
| Trulicity single-dose pen | 1.5 mg / 0.5 mL | 2–8°C refrigerated | Up to 14 days at room temp |
| Trulicity single-dose pen | 3.0 mg / 0.5 mL | 2–8°C refrigerated | Up to 14 days at room temp |
| Trulicity single-dose pen | 4.5 mg / 0.5 mL | 2–8°C refrigerated | Up to 14 days at room temp |
- Pre-filled pen — Designed for single patient use, single dose delivery. Discard after use.
- Temperature stability — Refrigerate 2–8°C long-term. Do not freeze. If exposed to freezing temperature, discard the pen (freezing denatures the fusion protein).
- Room-temperature window — Up to 14 days at under 30°C is acceptable for convenience (travel, patient preference); still discard after 14 days even if unused.
- Injection technique — Rotate between abdomen (at least 2 inches from navel), thigh, and upper arm. Subcutaneous only. Pinch skin, insert pen perpendicular, hold while pen auto-injects to completion (approximately 5–10 seconds). Dispose in sharps container.
- Administration day — Any day of the week; same time preferred. Missed-dose guidance: if within 3 days of scheduled dose, take as soon as possible; if more than 3 days, skip and resume at the next scheduled weekly dose. Do not double up.
- Inspection — Solution should be clear and colorless. Do not use if cloudy, discolored, or particulate is visible.
→ Use the Kalios Dosing Calculator for dulaglutide scheduling
Side Effects & Risks
Important
Standard GLP-1 class side-effect profile, well-mapped from the AWARD trials — GI dominant, rare pancreatitis, boxed warning for thyroid C-cell tumors based on rodent data. This is a doctor conversation before starting Trulicity.
Dulaglutide's side-effect profile is the well-characterized GLP-1 class pattern, dominated by gastrointestinal effects that typically peak in the first 2–4 weeks and resolve with continued therapy.
- Gastrointestinal (most common, class effect) — Nausea, vomiting, diarrhea, abdominal pain, constipation, decreased appetite. Nausea is the most frequent reason for discontinuation. Typically worst during the first 2–4 weeks of therapy and after dose increases; most patients acclimate. Slow titration and smaller meal sizes mitigate.
- Injection site reactions — Mild erythema, pruritus, or induration at the injection site. Usually self-limiting. Rotate sites to reduce recurrence.
- Pancreatitis (rare but serious) — The GLP-1 class carries a label warning for acute pancreatitis. Absolute risk in clinical trials is low (less than 0.5% annually). Evaluate any new persistent severe abdominal pain; discontinue if pancreatitis is suspected and do not restart.
- Thyroid C-cell tumors (boxed warning) — Rodent carcinogenicity studies demonstrated dose- and duration-dependent medullary thyroid tumors in rats. Relevance to humans is uncertain (rats are unusually sensitive to C-cell stimulation by sustained GLP-1 activation). Contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients on symptoms of thyroid tumors (neck mass, hoarseness, dysphagia, persistent throat symptoms).
- Hypoglycemia — Rare as monotherapy due to glucose-dependent insulin secretion. Risk rises significantly when combined with insulin or sulfonylureas. Dose-reduce the secretagogue or insulin when adding dulaglutide.
- Gallbladder disease — The GLP-1 class has a modest signal for cholelithiasis and cholecystitis, particularly in the context of rapid weight loss. Evaluate new upper-abdominal pain with appropriate imaging.
- Acute kidney injury — Usually in the context of severe volume depletion from GI adverse effects; maintain hydration.
- Diabetic retinopathy complications — Rapid improvements in glycemic control can temporarily worsen retinopathy. Pre-treatment retinal evaluation is prudent in patients with known retinopathy.
- Hypersensitivity reactions — Rare; includes urticaria, angioedema, and anaphylactoid reactions. Discontinue if hypersensitivity is suspected.
- Pregnancy and lactation — Limited data; use only if benefit justifies potential risk. Discontinue at least 1 month before planned conception given the long half-life.
- Drug interactions — Delayed gastric emptying can alter absorption of oral medications; monitor INR more frequently if co-administered with warfarin; consider timing of thyroid hormone dosing. No significant interactions with CYP450 pathways.
- Immunogenicity — Low rates of anti-drug antibody formation in clinical trials; neutralizing antibodies rare. Clinical impact on efficacy has not been demonstrated.
Bloodwork & Monitoring
Dulaglutide is monitored using the standard T2D metabolic-care framework with additional attention to class-specific risks.
- HbA1c — Baseline and every 3 months until glycemic target, then every 6 months. The primary efficacy endpoint.
- Fasting glucose and self-monitored blood glucose — Baseline and as clinically indicated. Patients on insulin or sulfonylureas require closer monitoring for hypoglycemia, especially in the first weeks.
- Weight — Baseline and at each follow-up. Modest weight loss (2–5 kg) is the typical expectation.
- Renal function (eGFR, urine albumin-to-creatinine ratio) — Baseline and annually. Dulaglutide has favorable renal outcomes data and requires no dose adjustment across eGFR ranges, but baseline renal status informs overall care.
- Lipid panel — Baseline and per CV risk management guidelines.
- Thyroid symptoms (counseling-based, not routine lab) — No routine calcitonin monitoring per FDA label. Patient education on symptoms of thyroid C-cell tumors (neck mass, hoarseness, persistent dysphagia) is the standard of care.
- Pancreatic symptoms — Clinical assessment at visits. Evaluate any new severe abdominal pain with amylase/lipase and imaging as indicated.
- Retinopathy screening — Particularly in patients with pre-existing retinopathy or rapid glycemic improvement.
- Cardiovascular risk assessment — Blood pressure, lipids, smoking status, and statin/antihypertensive optimization per guidelines.
- Pregnancy screening — In women of reproductive potential, discuss family planning; discontinue at least 1 month before planned conception.
Commonly Stacked With
Metformin
Standard first-line T2D therapy and the most common background therapy in the AWARD trials. Mechanistically complementary (hepatic glucose output reduction and insulin sensitization vs GLP-1 receptor effects). No clinically significant interaction.
SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin)
Independent CV and renal outcomes benefits. Combined GLP-1 + SGLT2i has strong guideline endorsement for T2D with established CVD or CKD. Modest additional HbA1c reduction and additive weight loss beyond either alone.
Basal insulin (when combined)
GLP-1 + basal insulin is a well-established T2D regimen for patients needing additional glycemic control. Dose-reduce insulin by 10–20% when adding dulaglutide to reduce hypoglycemia risk. Weight-neutral or weight-loss vs weight-gain with insulin monotherapy.
Do not stack two GLP-1 agonists (or GLP-1 + GIP/GLP-1 co-agonist) — compete at the same receptor with additive GI toxicity and no efficacy benefit. Consider switching if dulaglutide is tolerated but glycemic/weight targets are not achieved.
Statins, antihypertensives, aspirin
Standard CV risk management layers. Dulaglutide's REWIND CV benefit is on top of, not instead of, guideline-based cardiovascular prevention.
→ Check compound compatibility in the Stack Builder
Regulatory Status
Current Status — April 2026
Dulaglutide (Trulicity®) is FDA-approved. The original approval (September 2014) was for improving glycemic control in adults with type 2 diabetes. The label was expanded in February 2020 to include cardiovascular risk reduction in adults with T2D with established CVD or multiple CV risk factors (based on the REWIND trial). In June 2020, the FDA approved the 3.0 mg and 4.5 mg weekly doses based on AWARD-11. In 2022, the pediatric indication was added for patients aged 10 years and older.
Dulaglutide is approved by the European Medicines Agency (CHMP positive opinion November 2014), Health Canada, TGA (Australia), PMDA (Japan), and most major global regulators. It is on the WHO Model List of Essential Medicines.
Dulaglutide is not a controlled substance, is not on the FDA Category 2 Bulk Drug Substances list, and is not part of HHS Secretary Robert F. Kennedy Jr.'s February 2026 reclassification announcement. As an FDA-approved biologic produced by Eli Lilly under strict GMP, it exists entirely within the conventional pharmaceutical regulatory framework — prescription-only, distributed through licensed pharmacies, not eligible for 503A/503B compounding.
WADA: GLP-1 agonists are not specifically named on the WADA Prohibited List as of the 2026 edition. Dulaglutide is used in clinical practice by athletes with T2D when medically indicated. Tested athletes in sports subject to weight-category rules should consult sport-specific guidance, as weight-loss pharmacology can fall under adjacent categories in some jurisdictions.
Cost & Access
Dulaglutide is available as branded Trulicity by prescription in the United States and globally. It is distributed by Eli Lilly through licensed pharmacies; there is no generic or biosimilar dulaglutide as of April 2026 (biosimilars for complex Fc-fusion biologics face a longer development runway than for smaller peptide hormones). Manufacturer patient-assistance programs exist for eligible patients, and formulary placement varies widely by payer.
Dulaglutide is not compoundable in the United States under current FDA rules. Unlike semaglutide and tirzepatide, dulaglutide has no "compounded analog" shortage history because supply of Trulicity has been relatively stable. The large Fc-fusion molecule is also substantially more difficult to synthesize in a 503A compounding pharmacy context than a smaller peptide like semaglutide — practical compounding of dulaglutide is not commercially viable.
Dulaglutide is unaffected by HHS Secretary Robert F. Kennedy Jr.'s February 2026 peptide reclassification announcement. That announcement targeted Category 2 peptide bulk substances (BPC-157, GHK-Cu, KPV, and others in the compounding-peptide space) and does not touch the FDA-approved biologic space where Trulicity resides.
Estimated pricing as of April 2026. Actual costs vary by provider, location, insurance, and prescription status. Kalios does not sell compounds.
Related Compounds
People researching dulaglutide often also look at these:
Daily GLP-1 receptor agonist (Victoza / Saxenda). First-generation GLP-1 with shorter half-life.
Oral small-molecule GLP-1 receptor agonist in Phase III for obesity and type 2 diabetes.
Dual GLP-1 / glucagon receptor agonist with emphasis on MASH (liver fat) alongside weight loss.
Triple GLP-1 / GIP / glucagon agonist. The most potent obesity drug in Phase III, ~24% body weight reduction.
Key References
- Dungan KM, Povedano ST, Forst T, González JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. PMID: 25220191.
- Wysham C, Blevins T, Arakaki R, Colon G, Garcia P, Atisso C, Kuhstoss D, Lakshmanan M. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014 Aug;37(8):2159-67. PMID: 24898306.
- Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-9. PMID: 26246459.
- Umpierrez G, Tofé Povedano S, Pérez Manghi F, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014 Aug;37(8):2168-76. PMID: 25114296.
- Nauck M, Weinstock RS, Umpierrez GE, Guerci B, Skrivanek Z, Milicevic Z. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014 Aug;37(8):2149-58. PMID: 24842984.
- Tuttle KR, Lakshmanan MC, Rayner B, Busch RS, Zimmermann AG, Woodward DB, Botros FT. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):605-617. PMID: 29937267.
- Frias JP, Bonora E, Nevarez Ruiz L, Li YG, Yu Z, Milicevic Z, Malik R, Bethel MA, Cox DA. Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11). Diabetes Care. 2021 Mar;44(3):765-773. PMID: 33334807.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, et al; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. PMID: 31189511.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Botros FT, Riddle MC, Rydén L, et al. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):131-138. PMID: 31189512.
- Cukierman-Yaffe T, Gerstein HC, Colhoun HM, Diaz R, García-Pérez LE, Lakshmanan M, Bethel A, Xavier D, Probstfield J, Riddle MC, et al. Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial. Lancet Neurol. 2020 Jul;19(7):582-590. PMID: 32534650.
- Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. PMID: 29397376.
- Glaesner W, Vick AM, Millican R, Ellis B, Tschang SH, Tian Y, Bokvist K, Brenner M, Koester A, Porksen N, Etgen G, Bumol T. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev. 2010;26(4):287-96. PMID: 20503261. (Molecular engineering of dulaglutide.)
- FDA. Trulicity (dulaglutide) Prescribing Information. Eli Lilly and Company, Indianapolis, IN. Current version 2024/2025.
- European Medicines Agency. Trulicity (dulaglutide) EPAR — Assessment Report. EMA/CHMP/578928/2014. (Original EU approval documentation.)
- American Diabetes Association. Standards of Care in Diabetes — 2024/2025. Pharmacologic Approaches to Glycemic Treatment. Diabetes Care 2024;47(Suppl 1).
Last updated: April 2026 | Profile authored by Kalios Peptides research team